NCT07414394

Tigulixostat (IBI128) vs Febuxostat in Gout

A Randomized, Double-Blind, Double-Dummy, Multi-Center, Phase III Study Comparing the Efficacy and Safety of Tigulixostat (IBI128) and Febuxostat in Chinese Subjects With Gout

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Innovent Biologics Technology Limited (Shanghai R&D Center) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to compare the efficacy of Tigulixostat (IBI128) versus Febuxostat on the proportion of Chinese adults with gout achieving a serum uric acid (sUA) level \< 360 μmol/L at Week 24. The study also evaluates safety, gout attacks, kidney function, inflammation, and quality of life over 52 weeks of treatment. Approximately 600 eligible participants will be randomized to receive either Tigulixostat or Febuxostat.

Conditions

• Gout

Interventions

Type	Name	Description
DRUG	Febuxostat	Participants in this group receive Febuxostat tablets together with dummy tablets matching Tigulixostat once daily during the 24-week core treatment period. Thereafter, participants switch to Tigulixostat tablets alone once daily during the 28-week extension treatment period.
DRUG	Tigulixostat	Participants in this group receive Tigulixostat (IBI128) tablets together with dummy tablets matching Febuxostat once daily during the 24-week core treatment period, with dose escalation per protocol. Thereafter, participants continue Tigulixostat tablets alone once daily during the 28-week extension treatment period.

Timeline

• Start date: 2026-03-17
• Primary completion: 2027-04-30
• Completion: 2027-10-30
• First posted: 2026-02-17
• Last updated: 2026-03-25

Locations

1 site across 1 country: China